“Safety and effectiveness of Bexsero have not been established in children younger than 10 years of age,” vaccine insert states…

The UK government has announced it will begin vaccinating babies two months of age and older against meningitis B, an audacious campaign undertaken despite published warnings from vaccine manufacturers.

“I am very proud that we will be the first country in the world to have a nationwide MenB vaccination program, helping to protect our children from a devastating disease,” Health Secretary Jeremy Hunt stated over the weekend.

UK officials made the announcement after reaching a pricing agreement, of which “details will not be disclosed,” according to New Scientist, with vaccine manufacturer GlaxoSmithKline after the pharmaceutical giant bought competitor Novartis’ vaccine division.

The vaccine schedule, launching in September, will be rigorous.

“The vaccine will be introduced into the UK routine programme for babies at 2, 4 and 12 months of age,” Meningitis.org explains.

“Once the vaccination programme begins, babies who are 3 and 4 months old should also be offered the vaccine. Those aged 3 months will receive 3 doses at 3, 4 and 12 months, and those at 4 months will receive 2 doses at 4 and 12 months of age.”

The Daily Mail estimates that “Nearly 800,000 babies each year would be eligible for the jab at an average annual cost of £16million.”

Bexsero is one of only two licensed vaccines that target meningococcal bacteria serogroup B, but lost in all the hype is the inoculation’s history, warnings from the manufacturer itself and the actual incidence of meningitis.

History

Back in 2013, UK health officials were skeptical not only about Bexsero’s cost, but its purported efficacy.

“This is a very difficult situation where we have a new vaccine against Meningitis B but we lack important evidence. We need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person,” said Director of Immunization at the Department of Health David Salisbury.

“We need to work with the scientific community and the manufacturer to find ways to resolve these uncertainties so that we can come to a clear answer.”

The perceived necessity for a vaccine grew in 2013 and again last year when media reports surfaced about meningitis “outbreaks” hitting college campuses, when in fact only a few students were infected.

Amid the outbreak in 2014, the CDC and the FDA approved Bexsero to be distributed at Princeton, while admitting “vaccinated individuals may still be able to carry the bacteria in their throats, which could infect others through close contact.”

Warnings

In a statement released in July 2013 by UK’s Joint Committee on Vaccination and Immunisation concerning the vaccine’s rejection, officials noted that a high incidence of fever following concomitant (concurrent) adolescent vaccinations could cause parents to avoid the vaccine.

JCVI also “noted that data are too limited to identify rare reactions to the vaccine.”

The final version of the vaccine’s insert states that its “safety,” particularly in young children, is an issue.

“Safety and effectiveness of BEXSERO have not been established in children younger than 10 years of age,” Novartis’ insert notes, adding that “Sufficient data are not available to establish the safety and immunogenicity of concomitant administration of BEXSERO with recommended adolescent vaccines.”

By August 2012, the federal Vaccine Adverse Events Reporting System (VAERS), which includes only a small fraction of the health problems that occur after vaccination in the U.S., had recorded more than 2,300 serious health problems, hospitalizations and injuries following, including 39 deaths with about 40% of the deaths occurring in children under age six.

Incidence

Last October, the FDA released a statement reporting the low, but sometimes fatal, incidence of meningococcal disease, saying, “about 500 total cases of meningococcal disease were reported in the United States in 2012 [0.00016 percent of the population]; of those cases, 160 were caused by serogroup B.”

In the UK, depending on who you ask, authorities estimate anywhere from 1,200 to about 3,200 people, out of a total population of 64.1 million (in other words, .005 percent), are infected with bacterial meningitis and associated septicaemia yearly.

Despite a low prevalence, the FDA used the “accelerated approval regulatory pathway,” or “fast track” to get Bexsero approved in the US earlier this year, granting it “breakthrough therapy status” ostensibly “intended to expedite the development and review of medical products that address a serious or life-threatening condition.” Other drugs fast-tracked include Merck’s deadly Vioxx and their Gardasil HPV vaccine.

GSK’s sleepy past

In 2013, an astounding 795 cases of narcolepsy had been reported following GSK’s Pandemrix swine flu vaccine, introduced in 2009. The vaccine, administered to an estimated 30 million people throughout England Finland, Sweden, Norway, Ireland, and France, caused more than 200 cases in Sweden alone.

In a follow-up press release, GSK blamed “other risk factors,” stating, “It is crucial we learn more about how narcolepsy is triggered and how Pandemrix may have interacted with other risk factors in affected individuals.”

Of course, none of this should be interpreted as underplaying the seriousness of the sometimes fatal disease, which can quickly kill or lead to the loss of limbs.